To initiate the review process of a new study, Veritas IRB requires the following documentation:

Review of Study Protocol and Central Documents

• Protocol Submission Form
• Study Protocol (English or French)
• Template Informed Consent Documentation
• Template research participant recruitment procedures (e.g. study advertisements)
• Written information to be provided to research participants (e.g. questionnaires, diaries)
• Investigator's Brochure or Product Monograph

For Investigative Sites participating in a multi-center trial supervised by Veritas IRB, the following documentation is required once the study protocol and central documents have been approved:

Review of Investigative Sites

• Principal Investigator and Site Submission Form
• Site-specific research participant recruitment procedures (e.g. study advertisements)
• Investigator and Co-Investigator's curricula vitae and current medical licenses
• Investigator's Study Budget
• Information regarding Investigator's compensation to research participants and method of disbursement
• Copy of the Investigator's Clinical Trial Agreement with the Sponsor

Whether your study is a multi-center clinical trial, an investigator-initiated trial or an observational trial – and regardless of whether you are a pharmaceutical sponsor, a CRO, an investigative site or a research institution – the study start-up process at Veritas IRB is essentially the same.

Submission process/timeline for full review

• Submissions must be received one week prior to each IRB meeting.
• Summaries of the IRB decisions are communicated the morning following the meeting.
• Detailed approvals are communicated within 48 hours of the meeting.

Submission process/timeline for expedited reviews

• Submissions that qualify may be submitted at any time
• Submissions are reviewed within 72 hours.

Once you have finished preparing your submission documents, please complete the following form, click on “Choose File” to select the file(s) for submission, and click “Upload Files” to complete the process.

Following the IRB's unconditional approval, Veritas IRB will prepare and produce site-specific informed consent documents – at no additional cost. Furthermore, we will send each investigative site a complimentary copy of Veritas IRB's Investigator Manual on the ethical conduct of research.